NCT05200923 Pelvic Health Electrically Evoked Recording (PEER) 2 Study

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 300 participants in total. It began in 2022-01-18 with a primary completion date of 2026-12-18.

Brief Summary

To collect physiological signals at several timepoints during the therapy evaluation period.

Eligibility Criteria

Inclusion Criteria: Overactive Bladder Criteria Inclusion Criteria 1. 18 years of age or older 2. Candidate for or undergoing Medtronic InterStim lead implant for labeled indication\* requiring an advanced evaluation 3. Willing and able to provide signed and dated informed consent 4. Willing and able to independently and accurately complete diaries, questionnaires, attend visits, and comply with the study protocol 5. Willing to maintain current regimen (dosage and frequency) of any OAB medication from baseline diary through the end of therapy evaluation 6. For subjects with urinary urge incontinence, have a diagnosis of OAB as demonstrated on a voiding diary by having a minimum of 3 episodes of urinary urge incontinence in the first 72 hours (Episodes must have a mild, moderate, or severe degree of urgency to meet this criterion) of the voiding diary. 7. For subjects with urinary frequency, have a diagnosis of OAB as demonstrated on a voiding diary with greater than or equal to 8 urgency frequency episodes per day within the first 72 hours of the voiding diary. Note\*: Candidate for or undergoing a Medtronic InterStim lead implant for labeled indication means that a clinical decision has already been made between a physician and the patient to undergo Medtronic Interstim lead implant to treat the subject's condition. This decision is to be made prior to discussing with the patient whether to enroll in the study. Non-Obstructive Urinary Retention Inclusion Criteria 1. 18 years of age or older 2. Candidate for or undergoing Medtronic InterStim lead implant for labeled indication\* requiring an advanced evaluation 3. Willing and able to provide signed and dated informed consent 4. Willing and able to independently and accurately complete diaries, questionnaires, attend visits, and comply with the study protocol 5. Willing to maintain current regimen (dosage and frequency) of any NOUR medication from baseline diary through the end of therapy evaluation 6. Have a diagnosis of non-obstructive urinary retention with an elevated postvoid residual (PVR) that has persisted for at least six months and is documented on two or more separate occasions. Note\*: Candidate for or undergoing a Medtronic InterStim lead implant for labeled indication means that a clinical decision has already been made between a physician and the patient to undergo Medtronic Interstim lead implant to treat the subject's condition. This decision is to be made prior to discussing with the patient whether to enroll in the study. Fecal Incontinence Inclusion Criteria 1. 18 years of age or older 2. Candidate for or undergoing Medtronic InterStim lead implant labeled indication\* requiring an advanced evaluation 3. Willing and able to provide signed and dated informed consent 4. Willing and able to independently and accurately complete diaries, questionnaires, attend visits, and comply with the study protocol 5. Willing to maintain current regimen (dosage and frequency) of any FI medication from baseline diary through the end of therapy evaluation 6. Have a diagnosis of fecal incontinence as demonstrated by 3-day a bowel diary as greater than or equal to 1 incontinent episode of more than staining (i.e., either slight, moderate, or severe soiling) Note\*: Candidate for or undergoing a Medtronic InterStim lead implant for labeled indication means that a clinical decision has already been made between a physician and the patient to undergo Medtronic Interstim lead implant to treat the subject's condition. This decision is to be made prior to discussing with the patient whether to enroll in the study. Exclusion Criteria: Overactive Bladder Criteria Exclusion Criteria 1. Currently enrolled or planning to enroll in an interventional clinical study that could potentially confound the study results (co-enrollment in an interventional study is only allowed when documented pre-approval is obtained from the Medtronic study manager or designee) 2. Implanted with a neurostimulator, pacemaker or defibrillator 3. Pelvic floor muscle dysfunction due to surgical intervention or injury 4. Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury (e.g., paraplegia) 5. History of diabetes unless the diabetes is well-controlled through diet and/or medications 6. Have symptomatic urinary tract infection (UTI) 7. Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component 8. Treatment of voiding behavior with botulinum toxin in the past 9 months or any plan to have botulinum toxin treatment during the study 9. Treatment of symptoms with tibial neuromodulation therapy in the last 3 months 10. Have knowledge of planned magnetic resonance imaging (MRIs) during the therapy evaluation portion of the study 11. Have knowledge of planned shortwave diathermy, microwave diathermy, or therapeutic diathermy 12. Women who are pregnant or planning to become pregnant 13. Current urinary tract mechanical obstruction (e.g. benign prostatic enlargement or urethral stricture) 14. Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements Non-Obstructive Urinary Retention Exclusion Criteria 1. Currently enrolled or planning to enroll in an interventional clinical study that could potentially confound the study results (co-enrollment in an interventional study is only allowed when documented pre-approval is obtained from the Medtronic study manager or designee) 2. Implanted with a neurostimulator, pacemaker or defibrillator 3. Pelvic floor muscle dysfunction due to surgical intervention or injury 4. Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury (e.g., paraplegia) 5. History of diabetes unless the diabetes is well-controlled through diet and/or medications 6. Have symptomatic urinary tract infection (UTI) 7. Treatment of symptoms with tibial neuromodulation therapy in the last 3 months 8. Have knowledge of planned magnetic resonance imaging (MRIs) during the therapy evaluation portion of the study 9. Have knowledge of planned shortwave diathermy, microwave diathermy, or therapeutic diathermy 10. Women who are pregnant or planning to become pregnant 11. Current urinary tract mechanical obstruction (e.g. benign prostatic enlargement or urethral stricture) 12. Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements Fecal Incontinence Exclusion Criteria 1. Currently enrolled or planning to enroll in an interventional clinical study that could potentially confound the study results (co-enrollment in an interventional study is only allowed when documented pre-approval is obtained from the Medtronic study manager or designee) 2. Implanted with a neurostimulator, pacemaker or defibrillator 3. Pelvic floor muscle dysfunction due to surgical intervention or injury 4. Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury (e.g., paraplegia) 5. Have uncorrected high grade internal rectal prolapse 6. Treatment of symptoms with tibial neuromodulation therapy in the last 3 months 7. Have knowledge of planned magnetic resonance imaging (MRIs) during the therapy evaluation portion of the study 8. Have knowledge of planned shortwave diathermy, microwave diathermy, or therapeutic diathermy 9. Women who are pregnant or planning to become pregnant 10. Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements

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